Managing the Needs of Care Home Residents With Dementia Through a Music Therapy Intervention

NCT ID: NCT05176444

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to implement and evaluate a music therapy intervention in care homes. The primary aim is to assess whether implementing the intervention will have an impact on unmet in care homes for people living with dementia. Researchers will also examine the feasibility of a music therapy programme in care homes and its effects on care staff and residents with cognitive impairment. Care home staff will also receive training with music therapists via video communications to help staff use music therapy techniques to support people living with dementia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This project aims to evaluate the feasibility and effectiveness of a 12-week music therapy programme in care homes for residents with cognitive impairment/dementia and care home staff using a non-randomised control design. Music therapy is widely recognised as beneficial for people living with dementia. However, little is known about its overall impact on quality of care in care homes.

Research questions:

1. Can a music therapy intervention improve quality of care in care homes by supporting residents' needs?
2. What are the effects of music therapy on residents with cognitive impairment and care home staff?
3. Is the implementation of a music therapy programme feasible in care homes?
4. For the treatment of symptoms of dementia, is music therapy a cost-effective treatment in care homes?

Intervention:

The team will invite a total of 84 participants from 12 care homes located across the North and South of England to take part in the study. This includes 48 participants with cognitive impairment/dementia and 36 care home staff. The team will recruit a qualified music therapist in each region to work within the care home to deliver the music therapy intervention.

Residents with cognitive impairment/dementia will be invited to receive twenty 30-minute individual music therapy sessions across 12 weeks. The therapy will be video recorded for training purposes. Data will be collected about residents to learn about their needs and any health and wellbeing symptoms. This will help inform music therapists about each individuals' specific needs so that they can tailor a suitable treatment approach. They will enable a meaningful, engaging therapeutic relationship to improve the health and wellbeing of residents. The sessions will focus on targeting specific behavioural and psychological symptoms of dementia by providing cognitive stimulation, communicative support and social connectedness.

Within the 12-week programme, care home staff participants will be invited to collectively receive music therapy training on four occasions during week 3, 6, 9 and 12. Each music therapist will demonstrate significant moments of their sessions to staff via short video clips from a music therapy session. They will provide clinical explanations to staff about the techniques they have used and why they are effective for the individuals with cognitive impairment.

Data collection:

The team will be collecting a range of qualitative and quantitative data. The researchers will use an integrated evaluative approach focussing on clinical and organisational outcomes to examine the research questions. As part of the non-randomised control design, six of the care homes will be in the intervention group and receive the music therapy programme. There will be 42 participants in this group (24 with cognitive impairment, 18 care home staff). The remaining six care homes will form the control group and receive treatment as usual. Baseline and post 12-week data will be collected from all homes to compare differences between groups. Within group data will also be compared from the intervention homes.

Once all of the data has been collected from the control group care homes, they will then go on to receive the music therapy programme with the same amount and ratio of participants.

Implications:

The study has the potential to improve the lives of care home residents living with cognitive impairment/dementia. It also has the potential to improve the work life of care home staff and generate better quality of care. Staff will be provided with the tools and understanding of music therapy techniques, so that the potential effects can be sustainable. Standardised protocols are needed to learn about how researchers and practitioners can work with the social care sector to implement an effective music therapy programme. The evaluation of this study will inform this sector about the feasibility and effectiveness of music therapy care in care homes. The study findings will provide valuable insights into how to transform the social care sector through psychosocial, non-pharmacological intervention at micro and macro level.

.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Impairment Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Music therapy intervention

Music therapy

Group Type EXPERIMENTAL

Music therapy

Intervention Type BEHAVIORAL

Individual music therapy sessions across 12-weeks with people with cognitive impairment/dementia. Music therapy training for care home staff at four time points across 12-weeks.

Control group - standard care

Standard care for residents with cognitive impairment. Staff will not receive music therapy training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music therapy

Individual music therapy sessions across 12-weeks with people with cognitive impairment/dementia. Music therapy training for care home staff at four time points across 12-weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants must be aged 50+ years
* Participants will be a resident of one of the 12 care homes taking part
* For each participant, there must be clinical evidence of cognitive impairment. This will be determined by a score of 24 or under on the SMMSE
* Each participant must display at least one behavioural/psychological symptom of dementia. This will be determined by a score of 4 or higher on the NPI-NH.


* Participants must be aged 18+ years
* Participants must have worked in the care home for at least 3 months
* Participants will be required to have in-depth knowledge of the resident participant(s). This will be determined through communications with home managers to ensure each staff member is paired with a resident they provide regular care for.

Exclusion Criteria

\- Participants who's health appears to be at risk which raises the concerns of their sustained involvement with the study. This would be evident from a health assessment from a general practitioner. Given that this is a music therapy study, this could also include people with a hearing impairment.


\- Staff who cannot adequately answer on behalf of the residents due to lack of knowledge of the residents.
Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Anchor Trust

OTHER

Sponsor Role collaborator

The Utley Foundation

UNKNOWN

Sponsor Role collaborator

Anglia Ruskin University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Helen Odell-Miller, PhD

Role: STUDY_DIRECTOR

Anglia Ruskin University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ridgemount

Banstead, Surrey, United Kingdom

Site Status

Oakleigh, Godstone

London, Surrey, United Kingdom

Site Status

Greenacres, Banstead

London, Surrey, United Kingdom

Site Status

Hatfield House

Doncaster, , United Kingdom

Site Status

Simon Marks Court

Leeds, , United Kingdom

Site Status

Oak Tree Lodge

Leeds, , United Kingdom

Site Status

Kimberly Court

Newquay, , United Kingdom

Site Status

Wharfside

Otley, , United Kingdom

Site Status

St Anne's

Saltash, , United Kingdom

Site Status

Prior Bank

Sheffield, , United Kingdom

Site Status

Herries Lodge

Sheffield, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-015-0082-4

This study has tested similar methods to those that are being used in the current study

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5491018/

This study has informed the current study of outcome measures to use

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7248378/

This study details the effects of music therapy on dementia and highlights the need for further trials

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U4-11662

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tailored Music Therapy for Dementia
NCT03011723 COMPLETED NA
The Music, Sleep and Dementia Study
NCT04157244 COMPLETED NA
Music Therapy in Alzheimer's Disease
NCT02020356 TERMINATED NA